FDA WARNING_LETTER - Public Bru Inc. - April 12, 2022

On March 18, 2022, the FDA issued a Warning Letter to Tony Borriboonratana and Borna Rangchi, regarding e-liquid products manufactured and sold via publicbru.com. The FDA determined these e-liquid products, including "Public Bru Graham Mother" and "Public Bru Graham Father Salt," are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without required premarket authorization orders, as mandated by section 910(a) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j).

Although the firm is a registered manufacturer with over 50 products listed, their Premarket Tobacco Product Application (PMTA) STN PM0002493, covering 10 products, received a Refuse to File determination on August 25, 2021. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject